FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106581566
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PECGETRO2
Catalog number
PECGETRO2
Device description
KIT, ROC MYRINGOTOMY
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106581566PackageGS11In Commercial Distribution
10197106581568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710658156650197106581566
1019710658156810197106581568

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956060447CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956021318CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-11
50197106824151CARDINAL HEALTHCardinal Health 200, LLCOGS2024-11-06
50197106783168CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-14
50197106795246CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-07
50197106766222CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-09
50197106739936CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-03
50197106757312CARDINAL HEALTHCardinal Health 200, LLCOGS2024-08-30
00840183527730BR Surgical, LLCBR Surgical, LLCOGS2024-08-09
00840183512941BR Surgical, LLCBR Surgical, LLCOGS2024-07-23
50197106708277CARDINAL HEALTHCardinal Health 200, LLCOGS2024-07-09
50197106616855CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106657803CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106585939CARDINAL HEALTHCardinal Health 200, LLCOGS2024-03-21
50197106592753CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-29
50197106549252CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-27